Apr. 27, 2013

Nina Smothers, the state Board of Pharmacy's representative to a task-force on compounding, reports on findings from an FDA national meeting at a Board of Pharmacy Meeting in January 2013 in Nashville. / Dipti Vaidya / File / The Tennessean

The legislation from the Health, Education, Labor and Pensions Committee draws distinctions between traditional compounding pharmacies and compounding manufacturers, giving the U.S. Food and Drug Administration clear authority to supervise the manufacturers.

“Last year’s meningitis outbreak was a nightmare for Tennesseans, and this legislation will help ensure that it never happens again,” said Sen. Lamar Alexander of Tennessee, ranking Republican on the committee. “Our goal with this bill is to put an end to FDA inaction and make clear who is on the flagpole — who is in charge and accountable for oversight of these pharmacies and manufacturers.”

The legislation emerged from the Senate committee, which is chaired by U.S. Sen. Tom Harkin, D-Iowa, with bipartisan support.

“This legislation is a significant step forward in protecting the public from unsafe compounded products,” Harkin said. “By clarifying FDA authority over high-risk compounding practices, this bill will enhance protections for patients taking compounded drugs and help prevent crises like last year’s tragic meningitis outbreak.”

The outbreak, tied to tainted steroids made by Massachusetts-based New England Compounding Center, has sickened 733 in the U.S., with 53 deaths. The outbreak was discovered in Tennessee, which has been one of the hardest-hit states.

A press release issued by the committee said the legislation “creates a uniform set of rules for compounding manufacturers across the country while preserving the states’ primary role in traditional pharmacy regulation.”

The committee plans to have a hearing in early May to discuss the proposed legislation.